drugs MODERATE Updated 2019-03-13

Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 m

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Recalled Product

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.

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Hazard / Issue

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall