CLASS II Drug recall · Reported 10 Mar 2021 · FDA Enforcement Report
Progesterone Capsules, 200 mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Progesterone Capsules, 200 mg, distributed nationwide in the US. The recall was initiated on 26 Feb 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0292-2021
- FDA event ID
- 87411
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Progesterone
- Manufacturer
- Dr. Reddys Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2021
- FDA classified
- 3 Mar 2021
- Reported
- 10 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 26 Feb 2021 | Recall initiated by company | |
| 3 Mar 2021 | Classified by FDA | +5 days |
| 10 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Which lots are affected?
Batch # 1399851P1, Exp 02/2021
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Progesterone recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone Injection USP, 500mg per (50mg/mL) Multiple Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone Injection, USP, 500 mg per (50mg/mL) Multiple-Dose Vial recalledProgesterone | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy | Coast Quality Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Progesterone 100mg/ML Inj # Ethyl Oleate Injectable recalled | Vita Pharmacy | Sterility | DC, PR |
| Drug | CLASS II | Progesterone 100mg/ML Mdv Oil Injection recalled | First Royal Care Co. LLC | Sterility | 7 states |